Position Summary The Senior Development and Sustaining Engineer is responsible for the development and maintenance of respiratory, anesthesia, and/or urological products. Under minimal direction, the incumbent will organize and manage multiple projects and ensure they are completed in a timely manner, create design ideas for new products, and develop creative solutions to existing products when problems arise or modifications are requested.
Principal Responsibilities - Conduct research and/or development projects associated with the design and/or modification of medical devices, components, models, or mechanisms.
- Prepare or coordinate formal documentation of the product designs, risk analysis, product specifications, market specifications, etc. according to established product development procedures. Initiate formal reviews to get approvals per procedures.
- Develop, maintain and publish product development plans for assigned projects with critical milestones and timelines.
- Develop and coordinate the running protocols for the validations of new or modified devices or components, including validations of the design, manufacturing process, assembly, packaging, and sterilization where applicable.
- Investigate and resolve technical problems involving product performance, production equipment, or facility systems affecting production.
- Coordinate the product design and development process with appropriate support departments such as engineering, regulatory, documentation, tooling, and manufacturing.
- Serve as project leader for assigned projects and follow up on all aspects of projects, including conducting reviews with support groups and outside resources where applicable.
- Prepare or follow up on preparation of design drawings, specifications, estimates of costs, mainframe updates, etc.
- Discuss and consult with sales staff or customer on product requirements and specifications where design or manufacturing problems are involved.
- Work with manufacturing in the justification and the selection of the manufacturing process. Assign projects and establish priorities to ensure datelines and goals are achieved.
- Develop assembly methods and procedures. Create engineering draws and specifications.
- Coordinate changes in process, tolling, and equipment identified to positively impact the manufacturing process, while staying within GMP guidelines.
- Coordinate the reporting on project status for all responsible projects. Direct reports in formal periodic project review meetings, to include cost reduction progress, capital spending, and expense status.
- Enhance personal growth and development through participation in education programs, current literature, training meetings and workshops.
- Participate actively in continuous quality improvement activities through compliance with safety standards.
- Demonstrate professional responsibilities by cooperating with other personnel to achieve department and interdepartmental goals and objectives and maintain good employee relations.
- Organize, evaluate, and coordinate engineering studies with professional, technical, and clerical staff of a product evaluation department.
- Analyze complex, technical and administrative problems and adopt an effective course of action.
- Conduct comprehensive studies and preparation of reports including recommendations.
- Make effective presentations to, and participate in, a variety of meetings and conferences with other companies and the public.
- Prepare clear and concise statements and reports.
Education / Experience Requirements - Bachelor s degree in Biomedical Engineering or closely related field. Possession of BS degree may be substituted for six (6) additional years of work experience in the design and/or modification of plastic components for the medical industry
- 5+ years experience in product development
- 3+ years experience leading medical device engineering projects
- Experience with injection molding, plastic extrusion and plastic part assembly process and methods required
- Experience with CAD (design/drafting) programs, including SolidWorks, preferred
Specialized Skills / Other Requirements - Solid understanding of and experience with:
- U.S. FDA GMP and ISO requirements for the design, validation, manufacturing processes, secondary operations and assembly of medical components and devices.
- ISO and ASTM testing methods for medical devices and general plastic components
- Principles and practices of professional engineering.
- Regulations pertaining to medical device design and design modifications.
- Demonstrated creativity and ingenuity in applying engineering principles and practices and drawing solutions from a wide range of experience.
- Effective written and oral communication skills and ability to present information to, and respond to questions from, various audiences.
- Ability to interpret and follow instructions furnished in written, oral, diagram, or schedule form.
- Intermediate knowledge of Microsoft Office Suite (Project, Word, Excel, and Access)
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Proven ability to establish and maintain effective working relationships with peers.
Working Conditions / Physical Demands Typical research lab and office environment; occasional work in manufacturing areas and some field work. Some exposure to the electrical/mechanical/power manufacturing or testing equipment, with occasional heat and noise exposure and exposure to dust.
May visit domestic and international (Mexico, Asia) manufacturing sites. Travel required up to 10%.
Associated topics: boiler, catia, mechanical, mechanism, motor, powertrain, proe, rotordynamic, turbine, vibration